FDA 510(k)

SpotLight/SpotLight Duo (with DLIR option)

K-Number: K230370 · 2023-10-13

Decision Date2023-10-13

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SpotLight/SpotLight Duo (with DLIR option) is a medical device manufactured by Arineta , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under approval number K230370. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpotLight/SpotLight Duo (with DLIR option)?

SpotLight/SpotLight Duo (with DLIR option) is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Arineta , Ltd.. The 510(k) number is K230370.

When was SpotLight/SpotLight Duo (with DLIR option) approved by the FDA?

SpotLight/SpotLight Duo (with DLIR option) received FDA 510(k) clearance on 2023-10-13, under approval number K230370.

What company makes SpotLight/SpotLight Duo (with DLIR option)?

SpotLight/SpotLight Duo (with DLIR option) is manufactured by Arineta , Ltd..

What is the FDA product code for SpotLight/SpotLight Duo (with DLIR option)?

The FDA product code for SpotLight/SpotLight Duo (with DLIR option) is JAK.

Other Devices by Arineta , Ltd.

K161066SpotLight CT K213465CardioGraphe K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.